The primary purpose of this study is to compare the effect of double doses of a study drug known as insulin peglispro and insulin glargine in participants who have type 2 diabetes. Participants will be treated for up to 11 weeks, and will take part in two study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.

Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

Drug: Insulin Peglispro

Administered SQ

Other Name: LY2605541

Experimental: Insulin Glargine

Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

Drug: Insulin Glargine

Administered SQ

Eligibility

Ages Eligible for Study:

18 Years to 70 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) classification, for ≥1 year.

Have hemoglobin A1c (HbA1c) levels ≤9.0% according to central laboratory testing at screening.

Have body mass index (BMI) ≤40.0 kilogram/square meter (kg/m^2).

Have been treated with stable doses of insulin for at least 30 days before screening with:

Basal insulin with daily doses ±30% of mean during the last 4 weeks.

Doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day.

If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the last 30 days.

Exclusion Criteria:

Are using prandial, self-mixed, or premixed insulin. Participants using prandial insulin may be switched to everyday (qd) glargine if investigator judges that the participant will still meet fasting glucose requirements for randomization.

If being treated with sulfonylureas (SUs) before screening, then must have SUs washed out between screening and randomization.

Use any of these concomitant medications: morphine, codeine, antidiuretics, glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide, exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within 90 days before screening.

Have hypoglycemia unawareness, defined as confirmed by laboratory test results or by historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L) without symptoms.

Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at screening, as determined by the local laboratory.

Have had any episode of severe hypoglycemia (defined by requiring assistance due to neurologically disabling hypoglycemia) within 6 months before entry into the study.

Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.

Have had a previous clinically significant episode of ketoacidosis as determined by the investigator (ketone bodies at fasting and without acidosis is acceptable) in the past 6 months.

Have history of renal transplantation, are currently receiving renal dialysis, or have estimated Glomerular Filtration Rate (eGFR) <60 milliliters/minute.

Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02132637